Systems and methods of unattended treatment of a subject&#39;s head or neck

ABSTRACT

In accordance with various aspects of the present teachings, systems and methods for applying treatment energy, e.g., electromagnetic radiation such as laser radiation in the visible and near infrared wavelengths, to body areas having bulges and fat deposits, loose skin, pain, acne and/or wounds. In some aspects, the systems and methods can enable relatively lengthy treatments to be performed by having the practitioner set-up and/or start the treatment, thereafter allowing the treatment to proceed safely and effectively without the continued presence of the practitioner.

CROSS-REFERENCED TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/485,178, filed on Apr. 11, 2017, which is a continuation in part ofSer. No. 15/138,020, filed on Apr. 25, 2016, now U.S. Pat. No.10,518,104, which claims priority to and the benefit of U.S. ProvisionalApp. No. 62/321,141, filed on Apr. 11, 2016, U.S. Provisional App. No.62/210,967, filed on Aug. 27, 2015, and U.S. Provisional App. No.62/151,894, filed on Apr. 23, 2015, each of which is incorporated hereinby reference in their entirety.

FIELD

The present disclosure relates generally to systems and methods forapplying energy (e.g., electromagnetic radiation such as laser radiationin the visible and near infrared wavelengths) to treat, for example,body areas having bulges and fat deposits, loose skin, pain, acne and/orwounds. In various aspects, the present disclosure particularly relatesto systems for effectively targeting certain regions of tissue, forexample, adipose tissue in a subject's head or neck region including thesubmental area that can cause the appearance of a “double chin.”

BACKGROUND

The benefits of being able to raise and/or lower the temperature in aselected region of tissue for various therapeutic and cosmetic purposeshas been known for some time. For instance, heated pads or plates orvarious forms of electromagnetic radiation, including microwaveradiation, electricity, infrared radiation and ultrasound havepreviously been used for heating subdermal muscles, ligaments, bones andthe like to, for example, increase blood flow, to otherwise promote thehealing of various injuries and other damage, and for varioustherapeutic purposes, such as frostbite or hyperthermia treatment,treatment of poor blood circulation, physical therapy, stimulation ofcollagen, cellulite treatment, adrenergic stimulation, wound healing,psoriasis treatment, body reshaping, non-invasive wrinkle removal, etc.Heating may be applied over a small localized area, over a larger area,for example to the hands or feet, or over larger regions of tissue,including the entire body Subcutaneous fat in the submental region(e.g., under the chin), for example, can be aesthetically unappealingand can cause undesirable cosmetic effects even after substantial weightloss due to the sagging of the skin.

While optical and near infrared (NIR) radiation (collectively referredto hereinafter as “optical radiation”) is generally both less expensive,and being non-mutagenic, safer than microwave radiation, the use ofoptical radiation has heretofore not been considered suitable for mostapplications involving heating of tissue at depth, the term “tissue atdepth” as used herein meaning tissue at the border zone of the dermisand hypodermis, some of which tissue may be in the lower dermis, mostlyat a depth deeper than 1 mm, and tissue below this border zone to adepth of up to about 50 mm. The reason why optical radiation has notbeen considered suitable is because such radiation is both highlyscattered and highly absorbed in surface layers of tissue, precludingsignificant portions of such radiation from reaching the tissue regionsat depth to cause heating thereof. In view of the energy losses due toscattering and absorption, substantial optical (including NIR) energymust be applied in order for enough such energy to reach a region oftissues at depth to have a desired effect. However, such high energy cancause damage to the surface layers of tissue, making it difficult toachieve desired photothermal treatments in tissue regions at depth. Forthese reasons, optical radiation has had limited value for therapeuticand cosmetic treatments on tissue at depth.

SUMMARY

In order to enable photothermal treatment of tissue regions at depth(e.g., hyperthermic treatment of fatty tissue), various aspects of thepresent teachings provide methods and systems for modulating theapplication of radiation (or modulating the intensity of the radiationapplied to the tissue) over an extended treatment time. By way ofnon-liming example, the photothermal treatment of fatty tissue can raisethe mean tissue temperature at a treatment site at depth above about 40°C., from about 40° C. to about 48° C., or from about 42° C. to about 46°C. by applying laser irradiation to the treatment site to maintain thissupraphysiological temperature (greater than 37° C.) at the treatmentsite over a relatively extended period of time (e.g., a few minutes tohours depending on the particular temperature applied). In some aspects,for example, the treatment radiation can be applied over a relativelylong duration (e.g., from about 3 to about 50 minutes, or from about 10to about 45 minutes, or from about 15 to about 35 minutes, or about 25minutes) to achieve the desired depth of treatment, thereby heatingfatty tissue to trigger heat-induced injury that causes the adipocytesto undergo apoptosis or lipolysis. The residual cellular debris isgradually removed by the body through inflammation and the resultantimmune system clearing process, which can take weeks to months dependingon the extent of injury at the site. Since the regeneration process ofadipose tissue is very slow (over years), the total volume of fat withinthe treatment area decreases due to loss of adipocytes that wouldotherwise act as storage units for fat.

Since the techniques described above involve applying treatment energythrough the patient's skin surface, peak temperatures generally occur ator near the patient's skin surface and decrease, sometimessignificantly, with depth. Notably, 46° C. or 48° C.′ is not the upperlimit of treatment, as higher temperatures (47-50° C. or more e.g. 60°C., 70° C., 80° C., etc.) can also be effective to denature cells andablate tissue, but these likewise raise the mean heat level in thenon-target tissues and possibly cause collateral damage. Because it isdesirable to confine the hyperthermic treatment to the target tissuewhile keeping temperatures of dermal tissue above the targeted tissue atdepth below injury threshold (i.e., lower than about 46-47° C.), theelectromagnetic treatment parameters (such as radiation pattern,fluence, exposure time, etc.) can be modulated over the extendedtreatment time, and in some aspects by taking into account the coolingrate on the skin surface, an optimized temperature profile/gradient inthe target tissue can be achieved during the treatment.

One exemplary technique, called Selective Photothermolysis (SPTL), hasbeen widely used for various photothermal therapies, such as hairremoval and superficial vascular treatment. The objective of SPTL is tochoose an energy source, e.g., laser light, having a specific wavelengththat is selectively or preferentially absorbed by the targeted tissue(such as adipocytes and lipid bilayer structures), with less absorptionand therefore less thermal effect on the surrounding tissues (such asepidermis). Optimal SPTL is achieved when the targeted tissue has a muchhigher energy absorption compared to other surrounding tissues.Frequently, this effect is controlled by selecting lasers havingparticular wavelengths for specific cosmetic purposes. But in certainprocedures, selection of wavelength alone is not itself sufficient tocreate a large enough energy absorption differential between target andnon-target tissues to achieve optimal therapeutic effects without somedegree of damage to surrounding non-target tissues. Approaches thatincrease the energy absorption differential and control heating at thetreatment site while lessening collateral damage of non-target tissuescan in some aspects involve modulating the radiation exposure throughpulsed applications of laser light. For example, in accordance withvarious aspects of the present teachings, the methods and systems canutilize a near infrared laser having a wavelength within the range of1064 nm that is selected based on its tissue penetrance and therelatively low absorption of the EMR by the major chromophores in theskin (e.g., melanin and water). Exemplary power densities are from about0.5 to about 10 W/cm², or from about 4 to about 6 W/cm², and aparticularly useful range is about 0.9 to about 1.4 W/cm².Alternatively, suitable systems can utilize a wavelength within therange of about 800 nm to about 1300 nm, selected based on tissuepenetrance, and power densities from about 0.5 to about 10 W/cm², orfrom about 4 to about 6 W/cm², and a particularly useful range is about0.9 to about 1.4 W/cm². To maintain an appropriate hyperthermictemperature range in the target tissue (e.g., about 40-47° C. in the fatlayer) while avoiding pain and other unwanted side effects related tooverheating, the laser can be modulated such that it can be pulsed so asto generate an on/off pattern or by modulating the intensity of thelaser (e.g., between a high intensity and low intensity), which causesthe temperature to cycle within the appropriate hyperthermic temperaturerange, as disclosed for example in U.S. Pub No. 20080103565 entitled“Method and Apparatus for Treatment of Cutaneous and SubcutaneousConditions” and U.S. Pub. No. 20070213792 entitled “Treatment of TissueVolume with Radiant Energy,” the teachings of which are incorporated byreference in their entireties. With the laser on (or at a desiredrelatively high intensity), the temperature can rise to the upper limitsof the desired range. A periodic pause in radiation (or a lowering ofthe intensity) permits temperatures in the target site (and non-targetsite) to drop. Optionally, cooling (especially of the upper non-targettissue) can be further enhanced by using external devices (e.g., contactcooling), while laser radiation can resume (or its intensity isincreased) before the target tissue temperature drops below theappropriate hyperthermic temperature range. In some embodiments,radiation is delivered through the contact cooled surface, whichcontinuously cools. Alternatively, contact cooling is modulated viapulse on and off in concert with the delivery of radiation. The pulsescan be repeated for the duration of the treatment (e.g., from about 3minutes to about 2 hours, from about 5 minutes to about 45 minutes, fromabout 15 minutes to about 35 minutes, or about 25 minutes).

With such extended treatment times, it may also be desirable that atleast some, if not all, of the treatment can be accomplished hands-freeand/or at times by the practitioner. By way of example, a hands freesystem in accordance with various aspects of the present teachings couldenable the practitioner to start treatment of a first patient with afirst system, and allow the practitioner to attend to or treat a secondsubject during the first subject's relatively long treatment time. Invarious aspects, such a substantially unattended approach can reduce thecosts associated with treatment by freeing up the practitioner's timeand potentially enable a less skilled practitioner to be able to conducta majority of the treatment. For example, a less skilled practitionercan check in with and talk to the patient, to get a sense of thepatient's comfort and then call in a more skilled practitioner to adjustthe treatment parameters if necessary. In accordance with some aspectsof the present teachings, the systems and methods for relativelyhands-free and/or substantially unattended treatment described hereincan provide treatment that is reliable, safe, and/or relativelycomfortable to the patient over the length of the treatment time. Inaddition, various aspects of the systems and methods disclosed enablecustomization so as to fit various body areas requiring treatment and/orthe isolation of the target treatment area. For example, in variousaspects, systems are provided for treating certain regions of adiposetissue on a patient's head or neck (e.g., a subject's submental area,jowls, cheeks), while helping to provide good optical coupling betweenthe treatment radiation source and the subject's skin and patientcomfort during the extended treatment time.

In accordance with various exemplary aspects of the present teachings, asystem for substantially unattended treatment of body tissue (e.g., inthe head or neck region) is provided, the system comprising a housingand at least one source of electromagnetic radiation for generatingtreatment energy contained within the housing. The system also comprisesa plurality of applicators, with each of the applicators being adaptedto be placed in proximity to a treatment region of tissue of a patient'sbody and comprising a window having a skin-contacting surface throughwhich the treatment energy is transmitted from the applicator to thetreatment region. A plurality of umbilical cords, each of which extendsfrom the housing to a distal end coupled to one of the plurality ofapplicators, defines a conduit through which treatment energy generatedby the at least one electromagnetic radiation source is delivered fromthe housing to the applicator (e.g., through at least one opticalwaveguide extending through the conduit). The system can also comprise aframe configured to be coupled to the patient's body in a fixed positionrelative to the treatment region and defining at least one aperture intowhich a surface of the treatment region can extend. The frame and atleast one applicator can be coupled to one another in a variety ofmanners, but are generally removably coupled such that at least aportion of the skin-contacting surface of the window is disposed incontact with at least a portion of the surface of the treatment regionextending into the aperture upon coupling the applicator with the frame.In some aspects, for example, the frame and the applicator can comprisecomplementary mating features for removably coupling the applicator tothe frame. By way of example, the frame can comprise a snap-fit couplingmechanism for removably coupling the applicator to the frame. In variousaspects, the system can additionally comprise an adjustable beltconfigured to be coupled to the frame for securing the frame to thepatient's body.

In some aspects, the housing can comprise at least one arm extendingfrom the housing for supporting the umbilical cords. For example, thearm can extend from the housing so as to be disposed above the patient'sbody when performing treatment so as to maintain secure contact betweenthe skin-contacting surface of the applicator and the portion of thesurface of the treatment region extending into the aperture of theframe. In various aspects, the housing can be maneuverable (e.g., it caninclude wheels to position the housing and the umbilical cords extendingtherefrom in a desired position) and/or the arm(s) can be adjustable soas to alter its orientation relative to the patient. In some exemplaryaspects, the arm can additionally comprise at least one brake (e.g., aroller brake) in contact with the plurality of umbilical cords so as tomaintain the umbilical cords at a desired position relative to thepatient. By way of example, the at least one brake can limit movement ofthe umbilical cords when performing treatment so as to facilitate securecontact between the skin-contacting surface of the applicator and theportion of the surface of the treatment region extending into theaperture of the frame when coupled to the applicator. Additionally oralternatively, the brake can enable a desired amount of lead of theumbilical cord to be maintained between the brake and the applicator atthe distal end of the umbilical cord. Moreover, each umbilical cord canbe associated with its own brake such that the desired lead for eachumbilical cord can be adjusted individually.

In various aspects, the frame can define a plurality of apertures, eachof which can isolate a portion of a target treatment region.Additionally or alternatively, two or more frames can be used to isolateportions of the target treatment region. In various aspects, the framecan be configured to be simultaneously coupled with two or more of theplurality of applicators such that the skin-contacting surface of eachof the applicators is disposed in contact with the portion of thesurface of the treatment region extending into one of the apertures. Insuch aspects, for example, the frame can comprise a hinge disposedbetween adjacent apertures such that the orientation of the aperturescan be adjusted relative to each other (e.g., upon tightening a beltcoupled to the frame about a portion of the subject's body).

In various aspect, the system can further comprise a cooling mechanismconfigured to cool the skin-contacting surface of the applicators whenperforming treatment. By way of non-limiting example, a fluid pathwaycan extend through the conduit for circulating cooling fluid between thehousing and the applicator via the umbilical cord.

Additionally, in some aspects, each of the applicators can comprise acontact sensor to determine whether the skin-contacting surface of thewindow is disposed in contact with the surface of the treatment region.

In various aspects of the present teachings, the system can comprise atleast one mask configured to be coupled to the frame and configured toocclude the aperture of the frame so as to prevent a portion of thesurface of the patient's body from extending into the aperture and intocontact with the window of the applicator. It will be appreciated inlight of the present teachings that the mask can also be coupled to acooling mechanism for cooling the mask during treatment. In someaspects, the mask can define an unmasked portion having an area smallerthan each of the window of the applicator and the aperture of the frameassociated with the mask, with each of the applicators comprising acontact sensor to determine whether the skin-contacting surface of thewindow is disposed in contact with the surface of the treatment regionextending through the unmasked portion. Additionally or alternatively,at least one of the size and shape of the unmasked portion can beadjustable, for example, so as to customize the tissue to which thetreatment energy is applied. To increase patient comfort during theprocedure, for example, in some aspects the frame can comprise askin-contacting surface disposed about the at least one aperture,wherein the skin-contacting surface of the frame is contoured to fit thearea of the patient undergoing treatment. By way of example, theskin-contacting surface can be curved or non-planar so as to accommodatethe submental region of a patient.

In accordance with various exemplary aspects of the present teachings, amethod for treating body tissue is provided, the method comprisingcoupling a frame to a patient's body in a fixed position relative to atreatment region of tissue, the frame defining at least one apertureinto which a surface of the treatment region extends. At least oneapplicator can be coupled to the frame, each applicator comprising awindow having a skin-contacting surface through which treatment energyis configured to be transmitted from the applicator to the treatmentregion, wherein at least a portion of the skin-contacting surface of thewindow is disposed in contact with at least a portion of the surface ofthe treatment region extending into said aperture upon coupling with theframe. Thereafter, treatment energy can be transmitted to the portion ofthe surface of the treatment region extending through the aperture ofthe frame and disposed in contact with the skin-contacting surface ofthe window, the treatment energy being generated by at least one sourceof electromagnetic radiation disposed in a housing and delivered to theapplicator via an umbilical cord extending from the housing to a distalend of the umbilical cord that is coupled to the applicator. In someaspects, coupling at least one applicator to the frame can comprisecoupling a plurality of applicators to the frame, wherein each of theapplicators is associated with a different umbilical cord and adifferent aperture of the frame configured to isolate a differentsurface of the treatment region.

In various aspects, the housing can additionally comprise at least onearm extending from the housing for supporting the umbilical cords, themethod further comprising disposing the arm above the patient's bodywhen performing treatment. In some exemplary aspects, the arm can alsocomprise at least one brake in contact with each of the plurality ofumbilical cords so as to maintain a desired amount of lead of eachumbilical cord between the at least one brake and the applicatorassociated with each umbilical cord.

In some exemplary aspects, coupling the frame to the patient's body cancomprise securing a belt coupled to the frame around at least a portionof the patient's body. By way of example, when the treatment regioncomprises one of submental, jowl, and neck tissue, the belt can besecured about the patient's head and/or neck. Alternatively, when thetreatment region comprises abdominal tissue, the flanks, the under-braarea (in the back or in the front), the belt can be secured about thepatient's torso, Finally, when the treatment region comprises tissue ofthe patient's arm or leg (e.g., where the thighs meet and/or the saddlebag area), for example, the belt can be secured around the patient's armor leg, respectively. In various related aspects, the frame can comprisea hinge disposed between adjacent apertures, wherein coupling the frameto the patient's body further comprises adjusting the orientation of theapertures relative to each other (e.g., as the belt is tightened aboutthe patient).

In various aspects, the method can also include coupling the frame to atleast one mask configured to occlude a portion of the frame's apertureso as to prevent a portion of the surface of the patient's body fromextending into the aperture and into contact with the window of theapplicator. The unmasked portion of the mask can have an area smallerthan each of the window of the applicator and the aperture of the frameassociated with the mask, the method further comprising adjusting atleast one of the size and shape of the unmasked portion (e.g., so as tocustomize the tissue to which the treatment energy is applied).

In accordance with various aspects of the present teachings, a harnessis provided to facilitate treatment of portions of a patient's body, forexample, by improving patient comfort as the treatment is being applied,to ensure effective contact with the treatment region for effectivecoupling of the treatment energy into the skin, and/or to improvepatient safety. By way of example, in some exemplary aspects, a harnessis provided to facilitate treatment of a region of a subject's head orneck (e.g., the submental region, jowls, cheeks), the harness comprisingan encircling portion configured to be secured to at least a portion ofthe subject's head (e.g., the encircling portion surrounds all or aportion of the subject's head) and a brim extending anteriorly from theencircling portion and configured to be disposed anterior to thesubject's forehead when the encircling portion is secured to thesubject's head, the brim comprising a plurality of anterior couplingelements on each lateral side of the subject's head anterior to thesubject's temple. The harness can also comprise at least one framedefining at least one aperture into which a surface of the subject'sskin can extend when the frame is secured to the desired treatmentregion of the subject's head or neck (e.g., the submental region, jowls,cheeks), the at least one frame being configured to be coupled to atreatment applicator (e.g., as described otherwise herein) comprising anwindow through which treatment energy is transmitted from the treatmentapplicator to the treatment region. At least one anterior connector canbe provided comprising a superior mating feature configured toreleasably couple to each of the plurality of anterior coupling elementsof the brim on at least one lateral side of the subject's head so as tosecure the frame to the subject's treatment region. The window may be anoptical window to transmit optical energy. The window can enable othernon-optical forms of treatment energy (e.g., RF energy) to betransmitted to the treatment region. The treatment region can includethe lower part of the subject's head, such as the submental region,jowls, and cheeks, for example In various aspects, the encirclingportion can be configured to be secured to a subject's head above thelevel of the subject's ears. Additionally, in some aspects, theencircling portion can comprise a padded region configured to bedisposed against the subject's forehead. A length of the encirclingportion (e.g., a circumference or a portion of a circumference) can beadjustable to secure the encircling portion about the patient's head.Additionally, in some aspects, a superior connector can extend betweenopposed lateral sides of the encircling portion such that the superiorportion can provide further support, for example, by being disposedagainst the top of the subject's head. In related aspect, the length ofthe superior connector can also be adjustable.

The brim can be coupled to the at least one frame in a variety ofmanners in accordance with the present teachings. By way of example, theharness can comprise two anterior connectors and the frame can comprisea lateral coupling element on each lateral side of the frame, each ofthe two anterior connectors comprising a superior mating featureconfigured to releasably couple to each of the plurality of anteriorcoupling elements of the brim on one lateral side of the subject's headand an inferior mating feature configured to couple to the lateralcoupling element on the corresponding lateral side of the frame. In somerelated aspects, a length of each of the two anterior connectors can beadjustable after the superior mating feature is coupled to a selectedanterior coupling element of the brim and the inferior mating feature iscoupled to the lateral coupling element on the corresponding lateralside of the frame. Additionally, in various aspects, the encirclingportion can comprise a posterior coupling element on each lateral sideof the subject's head above and/or posterior to the subject's ears whenthe encircling portion is secured to the subject's head and the framecan comprise at least two lateral coupling elements on each of lateralsides of the frame. In such aspects, the harness can further comprisetwo posterior connectors each of which can comprise a superior matingfeature and an inferior mating feature, with each of the superior matingfeatures being configured to releasably couple to a posterior couplingelement on one lateral side of the subject's head and each of theinferior mating features being configured to couple to the lateralcoupling element on the corresponding lateral side of the frame. In someaspects, a single anterior connector can be provided, for example, theanterior connector comprising two superior mating features, each ofwhich is configured to couple to one of the plurality of anteriorcoupling elements on opposite lateral sides of the brim. In suchaspects, the anterior connector can pass under the chin from one lateralside to the other and can be coupled to the frame (e.g., passed througha coupling loop extending from the frame) so as to fix the position ofthe frame against the treatment region. Additionally in some aspects,for example, in which a plurality of frames are provided (e.g., fietreatment of the jowls or cheeks), the plurality of frames can beconnected to one another (e.g., via strap passing under the patient'schin or via a hinge that connects adjacent frames) and also with matingelements from one lateral side of each frame being coupled to theanterior coupling elements on that lateral side of the brim.

In some aspects, the encircling portion can also comprise a posteriorcoupling element on each lateral side of the subject's head, forexample, above and/or posterior to the subject's ears when theencircling portion is secured to the subject's head. In related aspects,the harness can further comprise two posterior connectors and the framecan comprise a lateral coupling element on opposite lateral sides of theframe, wherein each of the two posterior connectors comprises a superiormating feature and an inferior mating feature, the superior matingfeature being configured to releasably couple to the posterior couplingelement on one lateral side of the subject's head and the inferiormating feature being configured to couple to the lateral couplingelement on the corresponding lateral side of the frame. In relatedaspects, a length of each of the two posterior connectors can beadjusted prior to or after the superior mating features is coupled tothe posterior coupling element of the encircling portion and theinferior mating feature is coupled to the lateral coupling element onthe corresponding lateral side of the frame. In some aspects, theharness can comprise at least one posterior connector comprising atleast one mating feature configured to couple to the posterior couplingelements on each lateral side of the subject's head.

In various aspects, a length of the at least one anterior connector canbe adjusted prior to or after the superior mating feature is coupled toone of the plurality of anterior coupling elements of the brim.Additionally or alternatively, the anterior connector comprises at leastone of an elastic, a strap (e.g., a fabric strap made out of materialssuch as nylon), and a rigid element. In some aspects, the length of thestrap can be adjustable.

In some aspects, the frame and the applicator can also comprisecomplementary mating features for removably coupling the applicator tothe frame. By way of example, the frame can comprise a snap-fit couplingmechanism for removably coupling the applicator to the frame. In variousaspects, the at least one frame can define a plurality of apertures, theframe being configured to simultaneously couple to two or moreapplicators such that a skin-contacting surface of each of saidapplicators is disposed in contact with a portion of the treatmentregion submental region of jowls) In some related aspects, the frame(s)can comprise a hinge and/or connector disposed between adjacentapertures such that the orientation of the apertures can be adjustedrelative to each other. In such aspects, for example, the hinge orconnector can be placed under the patient's chin, with mating elementsfrom one lateral side of each frame being coupled to the anteriorcoupling elements on that lateral side of the brim. In some aspects, atleast one mask can be coupled to the frame and can be configured toocclude a portion of the aperture of the frame so as to prevent aportion of the surface of the subject's body from extending into theaperture and into contact with the window of the applicator. Forexample, the mask can define an unmasked portion having an area smallerthan each window of the applicator and the aperture of the frameassociated with the mask. In some aspects, the size and shape of theunmasked portion can be adjustable, can come in a range of unmaskedaperture sizes with smaller mask aperture sizes making a greater portionof the applicator “visible” to the patient's tissue and larger maskaperture sizes making a lesser portion of the applicator “visible to thepatient's tissue”, and can come in a variety of shapes to addressdifferent treatment areas and/or different treatment requirements.Additionally or alternatively, the frame can comprise a skin-contactingsurface disposed about the at least one aperture, wherein theskin-contacting surface of the frame about each of the at least oneaperture is non-planar.

In accordance with various aspects of the present teachings, a method oftreating a region of a subject's head or neck is provided, the methodcomprising coupling a harness to a subject's head such that anencircling portion of the harness is secured around at least a portionof a subject's head and a brim extending anteriorly from the encirclingportion is disposed anterior to the subject's forehead, the brimcomprising a plurality of anterior coupling elements on each lateralside of the subject's head anterior to the subject's temple. A superiormating feature of an anterior connector can be coupled to one of theplurality coupling elements of the brim and at least one frame coupledto the anterior connector can be disposed in contact with the desiredtreatment region (e.g., the subject's submental region, jowls, cheeks)such that a surface of the subject's skin extends through at least oneaperture of the frame. A treatment applicator can be coupled to the atleast one frame and treatment energy (e.g., EMR or RF energy) can beapplied to the treatment region through the window and an aperture inthe frame. As discussed throughout this disclosure in accordance withexemplary of the present teachings, the location of the coupling of theanterior connector to the brim can be adjusted so to improve patientcomfort as the treatment is being applied, to ensure effective contactwith the treatment region for effective coupling of the treatment energyinto the skin, and/or to improve patient safety. For example, in someaspects, the method can comprise de-coupling the superior mating featureof the anterior connector from said one of the plurality couplingelements of the brim and coupling with another of said plurality ofcoupling elements of the brim, for example, to change the angle by whichthe anterior connector couples the frame to the harness. The selectionof the location of the coupling element on the brim can be made toimprove the subject's comfort during treatment, to avoid contact betweenthe side of the frame and/or applicator and the subject's neck and thesense of choking that such contact can elicit, and/or to enable safetyglasses to be worn comfortably. Additionally or alternatively, a lengthof the one or more anterior connectors can be adjusted.

In some aspects, methods in accordance with the present teachings cancomprise coupling an anterior connector to an anterior coupling elementon each lateral side of the subject's head. In various aspects, theencircling portion can comprise a posterior coupling element on eachlateral side of the subject's head above and/or posterior to thesubject's ears, the method further comprising coupling a superior matingfeature of each of two posterior connectors to the posterior couplingelements on the corresponding lateral side of the subject's head. Insome related aspects, the method can comprise adjusting a length of thetwo posterior connectors.

In some aspects, coupling the harness to the patient's head can compriseadjusting a length of the encircling portion. Additionally, in someaspects, the harness can comprise a superior connector extending betweenopposed lateral sides of the encircling portion, the method furthercomprising adjusting a length of the superior connector to be disposedagainst the top of the subject's head.

These and other features of the applicant's teachings are set forthherein

BRIEF DESCRIPTION OF THE DRAWINGS

The skilled person in the art will understand that the drawings,described below, are for illustration purposes only. The drawings arenot intended to limit the scope of the applicant's teachings in any way.

FIG. 1 shows an exemplary system for providing photothermal treatment ofa target region of a patient's body in accordance with various aspectsof the present teachings. As shown, the system includes a housing, aplurality of umbilical cords extending therefrom that are supported byan arm, and an applicator disposed at the distal end of each umbilicalcord.

FIG. 2 shows a view of the system of FIG. 1 depicting the arm inadditional detail. As shown, the arm includes a brake mechanismassociated with each umbilical cord to assist in controlling thepositioning and/or securement of the applicator. The housingadditionally include a dock for storing the applicators when not in use.

FIG. 3 depicts another view of the system of FIG. 1 showing theexemplary brake mechanism in additional detail.

FIG. 4 depicts a close up of the exemplary brake mechanism.

FIG. 5 schematically depicts a cross-section of an exemplary umbilicalcord for use in the system of FIG. 1 .

FIG. 6 depicts additional detail of the applicator of FIG. 1 .

FIG. 7A-C depict the applicator of FIG. 6 coupled to an exemplary framehaving at least two apertures that can be secured to the patient inaccordance with various aspects of the present teachings.

FIG. 8 depicts a variety of exemplary frame configurations that can beemployed in the system of FIG. 1 .

FIGS. 9A-B depict additional detail of an exemplary frame for use inaccordance with various aspects of the present teachings, the framehaving a hinge disposed between the apertures for adjusting theorientation of the apertures when the frame is secured to the patient.

FIG. 10 depicts another exemplary frame having three apertures coupledto a belt for securing the frame about a portion of the patient's body.

FIG. 11 depicts another exemplary frame having four apertures secured toa patient's body via a belt disposed about the patient's torso, therebyisolating the region(s) for treatment with the applicator(s).

FIG. 12 depicts the exemplary frame of FIG. 10 , secured to a patient'sbody via a belt disposed about the patient's torso, with one applicatorbeing coupled to the frame so as to treat the treatment region withinone of the three apertures.

FIG. 13A depicts the exemplary frame of FIG. 11 , secured to a patient'sbody via a belt disposed about the patient's torso, with fourapplicators being coupled to the frame so as to treat the treatmentregion within each of the frame's four apertures.

FIG. 13B depicts two exemplary systems shown in FIG. 1 , with fourapplicators from one of the systems and two applicators from the othersystem being utilized to treat a body area isolated by six apertures ofmultiple frames that are tightened onto the subject via a belt loopedaround the subject's body.

FIG. 14 depicts the submental treatment region.

FIGS. 15A-B depict an exemplary applicator/frame/mask sub-assembly foruse in the system of FIG. 1 , in accordance with various aspects of thepresent teachings.

FIGS. 16A-D depict the exemplary applicator/frame/mask sub-assembly ofFIGS. 15A-B further coupled to a belt for securing the sub-assembly tothe patient's head for treatment of the submental region, in accordancewith various aspects of the present teachings.

FIGS. 17A-C depict an exemplary sub-assembly having two applicatorscoupled to two masked frames, together with a belt system for attachingthe two frames to one another and to secure the frames to the subject'sbody for treatment of the jowl's, in accordance with various aspects ofthe present teachings.

FIGS. 18A-E depict another exemplary sub-assembly having two applicatorscoupled to a masked frame, each of the applicators being associated witha separate aperture of the frame, and a belt system for securing theframe to the subject's body for treatment of the submental region, inaccordance with various aspects of the present teachings.

FIGS. 19A-D depict another exemplary sub-assembly having two applicatorscoupled to a masked, hinged frame, each of the applicators beingassociated with a separate aperture of the frame (with the middleaperture not being associated with an applicator), and a belt system forsecuring the frame to the subject's body for treatment of the neckregion, in accordance with various aspects of the present teachings.

FIGS. 20A-C depict another exemplary sub-assembly for treating the neckregion in accordance with various aspects of the present teachings, thesub-assembly having two applicators coupled to a masked, hinged frame,each of the applicators being associated with a separate aperture of theframe, and a belt system for securing the frame to the subject's body.

FIGS. 21A-C depict another exemplary sub-assembly for treating the neckregion in accordance with various aspects of the present teachings, thesub-assembly having two applicators coupled to a masked, hinged frame,each of the applicators being associated with a separate aperture of theframe, and a belt system for securing the frame to the subject's body.

FIG. 22A-C depict another exemplary applicator/frame/mask sub-assemblyfor use in the system of FIG. 1 in which the skin-contacting surface ofthe frame is contoured (non-planar) to improve patient comfort duringtreatment of the submental region in accordance with various aspects ofthe present teachings.

FIG. 23 schematically depicts another exemplary applicator/frame/masksub-assembly in accordance with various aspects of the present teachingsfor treatment of the submental region.

FIG. 24A shows a front view of an exemplary harness secured to apatient's head in accordance with various aspects of the presentteachings.

FIG. 24B shows a side view of the exemplary harness of FIG. 24A.

FIG. 24C shows a side view of the exemplary harness of FIG. 24A that iscoupled to an exemplary applicator in accordance with various aspects ofthe present teachings.

FIG. 24D shows a front view of the exemplary harness of FIG. 24A securedto a patient's head for treatment of a jowl in accordance with variousaspects of the present teachings.

FIG. 24E shows a side view of FIG. 24D.

FIG. 25 shows a front view of a schematic representation of an exemplaryharness placed on a human model's head in accordance with variousaspects of the present teachings.

FIG. 26 shows a front view of the exemplary harness of FIG. 25 .

FIG. 27 shows a perspective view of a brim of the exemplary harness ofFIG. 25 in additional detail.

FIG. 28A shows a right side perspective view of the exemplary harness ofFIG. 25 .

FIG. 28B shows a left side perspective view of the exemplary harness ofFIG. 25 .

FIG. 29 shows a perspective view of a portions of a padded encirclingportion of the exemplary harness of FIG. 25 .

FIG. 30 shows a rear view of the exemplary harness of FIG. 25 .

FIG. 31A shows a top view of the exemplary harness of FIG. 25 .

FIG. 31B shows a bottom view of the exemplary harness of FIG. 25 .

FIG. 32A depicts another exemplary mask for use in aapplicator/frame/mask sub-assembly in accordance with various aspects ofthe present teachings.

FIG. 32B depicts the patient-facing side of the exemplary mask of FIG.32A.

FIG. 33A depicts a portion of an exemplary applicator/frame/masksub-assembly with the mask of FIG. 32A in accordance with variousaspects of the present teachings.

FIG. 33B depicts the patient-facing side of the exemplaryapplicator/frame/mask sub-assembly of FIG. 33A.

DETAILED DESCRIPTION

It will be appreciated that for clarity, the following discussion willexplicate various aspects of embodiments of the applicant's teachings,while omitting certain specific details wherever convenient orappropriate to do so. For example, discussion of like or analogousfeatures in alternative embodiments may be somewhat abbreviated.Well-known ideas or concepts may also for brevity not be discussed inany great detail. The skilled person will recognize that someembodiments of the applicant's teachings may not require certain of thespecifically described details in every implementation, which are setforth herein only to provide a thorough understanding of theembodiments. Similarly it will be apparent that the describedembodiments may be susceptible to alteration or variation according tocommon general knowledge without departing from the scope of thedisclosure. The following detailed description of embodiments is not tobe regarded as limiting the scope of the applicant's teachings in anymanner.

In accordance with various aspects of the present teachings, systems andmethods for providing photothermal treatment of tissue at depth areprovided herein. In light of the extended treatment times typicallyutilized to perform such treatments, various aspects of the presentteachings provide systems and methods for a reliable, safe, and/orrelatively comfortable photothermal treatment to the patient in a mannerthat is relatively hands-free and/or with relatively little oversight,thereby potentially reducing the costs associated with continuedoversight by the practitioner. In addition, various aspects of thesystems and methods disclosed enable customization so as to fit variousbody areas requiring treatment and/or the isolation of the targettreatment area.

Referring now to FIG. 1 , an exemplary system 100 in accordance withvarious aspects of the present teachings is depicted. As shown, system100 provides for the non-invasive (or less-invasive) photothermaltreatment for fat reduction. Though the treatment is typically describedwith respect to the treatment of undesired body fat by the applicationof electromagnetic radiation to the fatty tissue through the externalsurface of the skin, it will nonetheless be appreciated by a personskilled that the systems and methods described herein can be utilized toprovide any number of photothermal treatments known in the art andmodified in accordance with the present teachings including thetreatment of loose skin pain, acne and/or wounds, all by way ofnon-limiting example. Exemplary approaches to photothermal treatment oftissue at depth and modified for use in accordance with methods andsystems of the present teachings are disclosed, for example, in U.S.Pub. No. 20070213792 entitled “Treatment of Tissue Volume with RadiantEnergy,”; U.S. Pub No. 20080103565 entitled “Method and Apparatus forTreatment of Cutaneous and Subcutaneous Conditions”; U.S. Patent Pub.No. 20140025033 entitled “Non-Invasive Fat Reduction by HyperthermicTreatment”; U.S. Pat. No. 7,276,058 entitled “Method and Apparatus ofTreatment of Cutaneous and Subcutaneous Conditions” issued on Oct. 2,2007: U.S. Pat. No. 7,351,252 entitled “Method and Apparatus forPhotothermal Treatment of Tissue at Depth” issued on Apr. 1, 2008; andU.S. Pat. No. 8,915,948 entitled “Method and Apparatus for PhotothermalTreatment of Tissue at Depth” issued on Dec. 23, 2014, the teachings ofwhich are incorporated by reference in their entireties.

As shown in FIG. 1 , the exemplary system 100 for the non-invasivetreatment of undesired body fat generally includes a housing 200 thatcan contain one or more sources of electromagnetic radiation (notshown), a plurality of umbilical cords 405 extending therefrom, and oneor more applicators 300 coupled to the distal end of the umbilical cords405 for applying the treatment radiation to the patient's skin whendisposed in contact with the surface of the treatment region. Though thedepicted exemplary system includes four applicators, any of a number ofapplicators 300 can be included in the system, for example, oneapplicator, two applicators, four applicators, or more. When not in use,the plurality of applicators 300 can be stored in a dock on the housing200. Suitable energy sources can be, for example, temperature control(e.g., cooling and/or heating), light based energy sources,electromagnetic radiation, radiofrequency (RF) energy, and ultrasoundenergy, as known in the art and modified in accordance with the presentteachings. As discussed in detail below, the treatment energy generatedby the EMR source(s) can be delivered to the applicator, for example,via an optical waveguide (e.g., optical fiber) coupled to the EMRsource(s) and extending through the umbilical cord 405.

As shown in FIGS. 1-4 , the system 100 additionally comprises an arm 420extending from the housing 200 that can support at least a portion ofthe umbilical cords 405, for example, above the subject to be treatedand/or at a desired distance from the patient and/or other portions ofthe system including, for example, the housing 200 containing the energysource. The arm 420 can extend upward and outward from the housing in avariety of manners so as to support the umbilical cords 405 about orrelative to the patient. As shown for example, the arm 420 includes asubstantially vertical portion 421 extending from an upper surface ofthe housing 200 and a substantially horizontal portion 422 that extendsfrom the top of the substantially vertical portion 421. The lengths ofthe vertical portion 421 and horizontal portion 422 can be fixed or canbe adjustable in order to obtain proper positioning of the umbilicalcords relative to the patient. By way of example, the arm 420 caninclude an adjustment mechanism (e.g., a telescoping portion hinge,pivot, or gimbaled mount) to adjust the length or angular orientation ofone or more portions of the arm 420. In some aspects, the substantiallyvertical portion 421 of the arm 420 can have a height, for example, thatis a function of the desired length (e.g., lead) of the umbilical 405including, for example, a height in a range from about 8 inches to about48 inches, from about 10 inches to about 36 inches, or about 12 inches.Likewise, the substantially horizontal portion 422 of the arm 420 canextend about 3 inches to about 36 inches, from about 9 inches to about24 inches, or about 12 inches from the substantially vertical portion421 such that the brake mechanism 410 (discussed in detail below)maintains the umbilical cords 405 at a distance of about 12 to 20 inchesfrom the substantially vertical portion 421 of the arm 420 and/or fromthe housing 200.

As noted above and best shown in FIGS. 3 and 4 , the arm 420 can alsoinclude a brake mechanism 410 for allowing the desired amount of leadfrom each of the plurality of umbilical cords 405 to be drawn toward thesubject being treated and/or to help ensure that the umbilical cords 405(and optionally additional umbilical lead) are at the desired positionselected by the user. Though the exemplary system 100 is shown toinclude opposing roller brakes 441 disposed at the distal most end ofthe arms 420 as discussed in detail below, it will be appreciated thatopposing roller brakes 411 is merely one approach to holding theplurality of umbilical cords 405 with some lead at a height above wherethe subject will be treated. Rather, it will be appreciated in light ofthe present teachings that any of a number of brake mechanisms can beemployed for hold the umbilical cord 405 (and optionally, additionalumbilical lead) at a desired position (e.g., height and/or distance)from the patient.

As noted above, the brake mechanism 410 comprises opposing roller brakes411 between which the umbilical cords 405 extend and which apply africtional or compression force to the cord 405 when disposedtherebetween. In this manner, the roller brakes 411 can enableadditional lead of the umbilical cord 405 to be pulled (e.g., with someresistance) toward the subject such that the skin-contacting surface ofthe applicator 300 attached to the umbilical cord 405 can sit with goodcontact on the skin surface of the patient. As otherwise discussedherein, the resistance and tension of the brake mechanism 410 enablesthe practitioner to tailor the amount of lead in each umbilical cord 405for each respective applicator 300 in view of how to effectively placeeach applicator 300 into a frame 400 so that the contact surface of theapplicator 300 is able to contact the subject's skin surface through theaperture 404 of the frame to ensure desired contact with the skincontact surface of the applicator 300 and the skin surface of thepatient.

In various aspects, a self-retraction and positioning feature can alsobe built into the umbilical cord 405. By way of example, a spring can bedisposed within a portion of the umbilical cord 405 (commonly referredto as a whip), that enables automatic retraction of the umbilical cord405. After a user has completed use of the applicator 300 and unfastensthe applicator 300 from the frame 400, for example, the user may simplypush the umbilical cord 405 upward toward the brake mechanism 410 with asingle hand. As a result the umbilical cord 405 can return to itsinitial position (e.g., as defined by stop 412 having a larger diameterthan the umbilical cord 405) by a single handed movement of the user,with the stop 412 being positioned to allow the applicator 300 to beseated in its dock.

It will be appreciated that umbilical cords 405 for use in accordancewith the present teachings can have a variety of configurations butgenerally define a conduit therethrough and are sufficiently flexiblesuch that they can be maneuvered into a desired position. By way ofexample, as shown in FIG. 5 , the exemplary umbilical cord 405 comprisesa corrugated, flexible outer surface 409A (e.g., made of plastic) aswell as a corrugated, inner shell 409B that is also flexible but can bemade of a material (e.g., metal, stainless steel) that providesincreased protection to the fibers and/or conduit extending through theconduit defined by the umbilical cord 405. For example, FIG. 5 depictsthat an optical waveguide (e.g., optical 406) extends through theconduit for delivering EMR from the EMR sources to the applicators.Additionally, as discussed in detail below, one or more fluid pathways407A,B can extend through the conduit, for example, for deliveringcooling fluid to and returning cooling fluid from the applicator 300.Additionally, one or more signal cables 408 can be provided to enableelectric communication between the housing 200 and the applicator 300(e.g., including for transmitting signals generated by contact sensorsof the applicators).

Referring now to FIG. 6 , the exemplary applicator 300 of FIG. 1 isdepicted in additional detail. As shown in FIG. 6 , the applicator 300(or treatment head) is coupled to the umbilical cord 405 (e.g., fordelivery of the treatment energy) and includes a window having askin-contacting surface 307 through which the treatment energy istransmitted from the applicator 300 to the treatment region (e.g., anoptical window). The window can have a variety of configurations butgenerally comprises a material selected to provide good energy couplingwith the skin when in contact therewith. By way of non-limiting example,an optical window can comprise glass or sapphire so as to provide goodoptical coupling with the skin when in contact therewith. It will alsobe appreciated that the contact surface 307 of the applicator 300 canhave a variety of sizes and shapes (e.g., depending on the surface to betreated) including rectangular, square, triangular, circular, oval,ellipse, trapezoid, rhombus, pentagon, hexagon, octagon, orparallelogram, all by way of non-limiting example. As shown in FIG. 5 ,for example, the contact surface is rectangular, and can have a shortside that ranges from about 1 cm to about 10 cm and a long side thatrange from about 2 cm to about 15 cm. In one exemplary embodiment, theshort side measures 3 cm and the long side measures 5 cm. In anotherexemplary embodiment, the short side measures 4 cm and the long sidemeasured 6 cm. In various aspects, the contact surface 307 can cover anarea that ranges from about 2 cm² to about 150 cm², or about 15 cm², orabout 24 cm².

With continued reference to FIG. 6 , the applicator 300 also includes aplurality of contact sensors 305 (e.g., eight contact sensors) thatensure contact with the skin surface during treatment. In oneembodiment, when there is incomplete contact or an absence of contactwith one of the contact sensors 305 with the skin surface, the systemtakes action to avoid injury. For example, when incomplete contact or anabsence of contact is detected, a controller in the system 100 will turnoff the energy delivered to the applicator 300, thereby inhibitingradiation transmission through the skin contact surface 307 of theapplicator 300. In another embodiment, when incomplete or an absence ofcontact is detected, by one or more of the contact sensors 305, thesystem 100 will lower the amount of energy (e.g., the intensity)delivered to the applicator 300 from the radiation source. Any of anumber of suitable contact sensors 305 may be employed, for example, anelectrical contact sensor (e.g., an electrical resistance sensor, anelectrical impedance sensor, a capacitance sensor), a pressure contactsensor (e.g., a mechanical sensor). In various aspects, the use ofcontact sensors can be valuable in that it preserves eye safety.Suitable approaches to ensuring contact between the treatment head andthe patient's skin and modified for use in accordance with methods andsystems of the present teachings are disclosed, for example, in U.S.Pub. No. 20060149343 entitled “Cooling System For a PhotocosmeticDevice” and U.S. Pat. No. 6,653,618 entitled “Contact Detecting Methodand Apparatus for an Optical Radiation Handpiece” issued Nov. 25, 2003,the teachings of which are incorporated by reference in theirentireties.

As noted above, it may also be desirable to cool the skin-contactingsurface 307 of the applicator 300 so as to cool the layers of the skinabove the target region at depth. In some aspects, for example, asdiscussed above with reference to FIG. 5 , one or more fluid pathways407A,B can extend through the conduit, for example, for deliveringcooling fluid to the applicator 300 for maintaining the skin-contactingsurface and/or the skin surface at a desired temperature (e.g., toconfine the hyperthermic treatment to the target tissue while keepingtemperatures of dermal tissue above the targeted tissue at depth belowinjury threshold) Additionally, where the applicator surface is cooled,the use of contact sensors prevents unwanted heating (e.g., in theepidermal and/or dermal layer) due to lack of contact and/or incompletecontact between the skin surface and the cooled applicator surface.Suitable approaches to cooling the skin during photothermal treatmentand modified for use in accordance with methods and systems of thepresent teachings are disclosed, for example, in U.S. Pat. No. 6,517,532entitled “Light Energy Delivery Head” issued on Feb. 11, 2003; U.S. Pat.No. 6,663,620 entitled “Light Energy Deliver Head” issued on Dec. 16,2003; U.S. Pat. No. 6,653,618 entitled “Contact Detecting Method andApparatus for an Optical Radiation Handpiece” issued Nov. 25, 2003; U.S.Pat. No. 6,974,451 entitled “Light Energy Delivery Head” issued on Dec.13, 2005; U.S. Pat. No. 6,976,985 entitled “Light Energy Delivery Head”issued on Dec. 30, 2005; U.S. Pat. No. 7,351,252 entitled “Method andApparatus for Photothermal Treatment of Tissue at Depth” issued on Apr.1, 2008; U.S. Pat. No. 7,763,016 entitled “Light Energy Delivery Head”issued on Jul. 27, 2010; U.S. Pat. No. 8,002,768 entitled “Light EnergyDelivery Head” issued on Aug. 23, 2011; U.S. Pat. No. 8,915,948 entitled“Method and Apparatus for Photothermal Treatment of Tissue at Depth”issued on Dec. 23, 2014, U.S. Pub No. 20080103565 entitled “Method andApparatus for Treatment of Cutaneous and Subcutaneous Conditions”, U.S.Pub. No. 20070213792 entitled “Treatment of Tissue Volume with RadiantEnergy”; and U.S. Pub. No. 20140025033 entitled “Non-Invasive FatReduction by Hyperthermic Treatment,” the teachings of which areincorporated by reference in their entireties.

As noted above, a self-retracting mechanism can be included with theumbilical cords that can assist in automatic retraction of the umbilicalcord 405 and applicator 300 after a user has completed use of theapplicator 300. In various related aspects, the applicator can weighabout 0.75 lbs, or from about 0.1 lb to about 10 lbs, or from about 0.25lbs to about 5 lbs, or from about 0.5 lbs to about 1.5 lbs, by way ofnon-limiting example. Each applicator together with the umbilical cordcan weigh about 3.5 lbs, or from about 0.75 lbs to about 15 lbs, or fromabout 15 lbs to about 7 lbs, or from about 2.5 lbs to about 5 lbs, byway of non-limiting example.

With reference now to FIGS. 7A-C, the applicator 300 is depicted asbeing removably attached to a frame, which as otherwise discussed hereincan be secured to the patient to isolate a treatment region and/or helpensure contact between the skin-contacting surface 307 of the applicator300 and a portion of the surface of the patient's skin tissue. As shownin FIG. 7A, the applicator 300 is mechanically attached to a frame 400having an applicator surface and a skin contact surface, and definingtwo apertures 404 therebetween. FIG. 7A depicts how the applicator 300is attached at the applicator surface to one of the two apertures 404 offrame 400, with the skin-contacting surface 307 of the applicator 300(as shown in FIG. 6A) contacting the subject's skin through the aperture404 of the frame 400. It will be appreciated that the applicator 300 andthe frame 400 can be removably coupled using any coupling mechanismknown in the art and modified in accordance with the present teachings.By way of example, FIGS. 7B and 7C depict an applicator 300 attaching toa frame 400 through the interaction between a male connector 302A on theapplicator 300 that snap fits with a complementary female connector 402Fon the applicator attachment side of the frame 400. Other exemplaryfastening systems for removably coupling the applicator to the frameinclude tension fit, clamp, clip, hook and eye, clothespin, buckle,bungee, or zip tie, all by way of non-limiting example.

Additional details of exemplary frames in accordance with variousaspects of the present teachings will now be discussed in more detail.With reference now to FIG. 8 , a number of exemplary frames 400 that maybe employed with the system of FIG. 1 are depicted. As shown in FIG. 8 ,frames 400A and 400B each have a single aperture 404, frame 400C has twoapertures 404, frame 400D has three apertures 404, and frame 400E hasfour apertures 404, with each of the apertures 404 of the frames 400A-Ebeing associated with a coupling mechanism (e.g., female connectors) onthe applicator side of the frame for removably coupling with anapplicator 300 (e.g., via snap fit connection) Additionally, as showneach of the frames 400A-E comprises tabs 408A/B that can be utilized tocouple to a belt (e.g., through one or more belt loops 407 extendingthrough the tabs 408A/B). It will be appreciated in light of the presentteachings that the number of apertures 404, the shape of the apertures(e.g., rectangle, square, circle, hexagon, triangle, etc.), the layoutof the apertures (linear pattern of apertures, brick pattern ofapertures, vertically stacked column of apertures, or horizontallystacked row of apertures), and the size of the apertures can becustomized for the desired treatment area. By way of example, where theregion for treatment is contoured (e.g., around the waist of thesubject) a frame having multiple hinged apertures may be used to enabletreatment of the contour of the body area. In one embodiment, eachaperture/applicator treats an area of from about 5 cm² to about 200 cm²,or from about 10 cm² to about 150 cm², or from about 25 cm² to about 100cm².

With reference now to FIGS. 9A-B, an exemplary frame 400 is shown inadditional detail in which a hinge 441 is disposed between portions offrame 400 so as to adjust the angular orientation of the adjacentapertures and/or change their proximity to one another. FIG. 9B showsthe skin contact side of the frame 400 and the regions where theapertures of the frame 400F are attached to one another via theplurality of hinges 441. For example, one or more hinges can attachadjacent frame portions to one another such that a first aperture offrame 400 is adjacent a second aperture of frame 400. In one embodiment,the hinges 441 are disposed on the skin contact side of the frame 400.The hinges 441 enable the frame 400 to follow the contour of thesubject's body, e.g., by articulating the curvature of the area to betreated. In one embodiment, the hinge 441 can be sized to minimizeseparation between adjacent apertures so that when treatment occursusing a frame having multiple apertures, the treatment is relativelyconsistent in the overall treatment area despite the distance betweenadjacent apertures.

As noted above, the frame can be secured to the patient, for example,prior to removably coupling the applicator to the frame. With referencenow to FIG. 10 , for example, the system 100 can include a belt 500having an attachment mechanism (e.g., buckles 504) that attach to theframe 400D via belt loops 407 extending through the tabs 408B disposedon the frame 400D. FIG. 11 , for example, depicts the belt 500tightening a hinged frame 400E having four apertures around the contourof a subject's body, thereby isolating within the four apertures of theframe a skin surface of the treatment region(s) 600 that extend (e.g.,bulge) into each aperture of the frame 4000.

FIG. 12 also shows a belt 500 tightening a hinged frame 4000 havingthree apertures around the circumference of a subject's body therebyisolating the region(s) for treatment 600 with the applicator(s). Asshown, the skin contact surface of the coupled applicator 300A is placedin contact with an isolated treatment region 600 having a bulge that ispresent in the aperture of the frame 400D. Referring still to FIG. 12 ,with the frame secured to the patient thusly, one or more applicators(e.g., up to four in the case of FIG. 11 ) can then be coupled to theframe 400D so that the skin-contacting surface 307 of each applicator300 contacts the skin bulges 600 through each aperture 404 in the frame4000. For example, the applicators 300 can be fastened to the frame 400Dby snapping the male connectors on each applicator 300 with thecomplementary female connectors on the frame 400D associated with eachaperture 404. The bulge of tissue through the aperture and the snap fitconnection between the applicator and the frame 400D ensure contact ofthe skin-contacting surface of the applicator with the surface of theskin tissue 600 that has bulged through the aperture. Optionally, lotioncan be disposed on the surface of the isolated region of skin tissue inthe aperture 600 prior to coupling the applicator (e.g., via snap fitplacement) to the frame and even prior to positioning the frame on thebody area to be treated. Suitable lotions can include, for example, babyoil or Palomar® lux lotion. Optionally, contact sensors disposed on theskin contact side of the applicator(s) avoid treatment of the skintissue when good contact is not in place. In this way, with a cooledapplicator skin contact surface, proper cooling of the skin tissue bythe applicator is provided and excessive heat treatment (e.g., burns)are avoided.

With reference now to FIG. 13A, treatment of a subject with the systemshown in FIG. 1 is depicted in which four applicators 300A, 300B, 300C,and 300D are coupled to frame 400E. As shown, the frame 400E istightened onto the subject via a belt 500 looped around the contours ofsubject's body so as to treat the regions of a body area isolated by theskin bulges present in the four apertures 404 of the frame 400E. Inaccordance with various aspects of the present teachings, the umbilicalcords are looped through the arm and the brake mechanism that introducethe applicator to the frame with a tension level that ensures goodcontact between the skin contacting surface of the applicator and thesubject's skin tissue. Each applicator is held by its respectiveumbilical and the umbilical is held from the arm of the system at adistance away from the energy source and at a height to help ensure goodcontact between the skin contacting surface of the applicator and thesubject's skin tissue. Moreover, as discussed above, the applicator isattached to the frame by a removable coupling mechanism such as a snaptit engagement. The tissue isolated within and bulging in the aperturesof the frame helps ensure that there is good contact between the skincontact surface of the applicator and the subject's skin tissue.Finally, optional lotion and optional contact sensors on the skincontact surface of the applicator enable the system to be used to treattissue only when contact (e.g., good contact and/or full contact) ispresent between the applicator surface and the skin surface.

As discussed otherwise herein, in this manner the subject can be “setup” for treatment by the practitioner and then require minimal to noadditional direct contact with or attention from the practitioner untilthe treatment time is completed (e.g., for from about 5 minutes to about2 hours) such that a safe, reliable, comfortable, non-invasive treatmentof fat tissue can be achieved while requiring minimal practitioner timeconsidering the length of time required to complete the treatment. FIG.13B demonstrates how the subject can be positioned relative to thesystem 100 in accordance with various aspects of the present teachings.As shown, the subject can be disposed (e.g., lie) under the arm toenable the applicator attached to the umbilical to be aided by gravityfrom each umbilical that is held within the arm by opposing rollerbrakes. Referring still to FIG. 13B, the subject is treated with twoseparate systems 100A, 100B using four applicators from one system 1008and two applicators from the other system 100A to treat an abdominalbody area isolated by six apertures of multiple frames. In oneembodiment, for example, two or more separate frames can be attached toone another via a link (e.g., a “c” shaped loop, substantially “o”shaped loop that has an opening in it that enables frames to be linkedtogether, or one or more snap fit connectors for connecting two or moreframes to one another). The frames can be tightened onto the subject viaa belt looped around the subject's body. Here regions of a body areaisolated by the six separate skin bulges present in six apertures of atleast two linked frames are tightened onto the subject via a belt loopedaround the contours of subject's body.

Additionally, the subject can be in the standing position when the areafor treatment is isolated by the belt/frame combination and thereaftersit down or lie down for treatment with the system. By isolating thebody area to be treated when the subject is in the position where theappearance of the body area is of most concern, the subject can becertain that his needs are being addressed and further the level ofexpertise to enable the treatment area to be isolated is lessened versusother treatment modalities. By isolating the treatment area in theframes while the subject is standing and prior to treatment, the subjectcan comfortably sit, recline, and or lay down during his treatment whileknowing that the areas of concern are being addressed by the treatment.

It will be appreciated in light of the present teachings, that thesystems and methods described herein can be customized or configured totreat specific treatment regions. For example, in addition to theabdominal treatments depicted in FIGS. 13A-B, a subject may have concernabout other areas on the torso like the flanks, tissue below the braarea (on the front or back), also, areas of arms or legs, or about theappearance of fat and fullness in the face, chin, and neck area, by wayof non-limiting examples. With specific reference to the submental area,the jowls, and the neck, these visible areas may be of concern to manypeople as they age and/or go through body weight changes. Small amountsof fat in the face, neck, and chin can make an otherwise fit personappear to carry more weight than the person actually carries.

FIG. 14 depicts the submental treatment region 610 of the face/neckarea. The submental treatment region 610 is the region of the lowerportion of the face/neck area that is located between the mandible downto the hyoid bone. Fat tissue can localize in the submental regionleading to an appearance of submental fullness that a subject findsundesirable. Current treatment options range from liposuction, which ishighly invasive, to a non-invasive approach that includes pressing acooled applicator against the submental region. Other treatment optionsare desired.

In accordance with various aspects of the present teachings, one or moreof the applicators 300 of the system 100 shown in FIG. 1 may be used totreat the undesired fat and fullness in the face, neck, and chin area.In one embodiment, for example, a standard frame 400 of the system 100can be modified to adjust the irradiation footprint/size of the contactsurface of the applicator so as to treat a relatively smaller submittalor jowl region with a standard applicator contact surface. In oneexemplary embodiment, each standard frame of the system can measureabout 4.8 cm by about 9 cm (or about 43.2 cm²) and each contact surfaceof the applicator can measure about 4 cm by about 6 cm (or about 24cm²). For example, in some embodiments disclosed herein, a mask portioncan be coupled or attached to the frame so as to mask all or a portionof the irradiation footprint of the applicator's skin-contacting surfacesuch that the irradiation surface of the contact surface is reduced(i.e., masked), For example, the mask portion can mask from about 0% toabout 80% of the contact surface of the applicator, from about 15% toabout 75% of the contact surface of the applicator, from about 25% toabout 50% of the contact surface of the applicator, or from about 35% toabout 45% of the contact surface of the applicator. In one exemplaryembodiment, where the footprint of the applicator contact surfacemeasures 24 cm², the effective treatment footprint of the contactsurface can be reduced to a range from about 23.76 cm² to about 4.8 cm²once masked. The mask portion blocks at least a portion of thetransmission from the contact surface of the applicator from reachingthe subject's tissue. Each mask portion may have a fixed size and shapeand multiple masks may be employed depending on the subject's treatmentarea, for example.

Alternatively, in some aspects, the mask portion can have an adjustablesize and/or shape. The mask portion can have any of a number of shapesthat may be selected depending on the area to be treated: The maskportion can have a shape that is selected from square, triangular,circular, oval, ellipse, trapezoid, rhombus, pentagon, hexagon, octagon,or parallelogram, for example.

In one exemplary embodiment, the mask portion is the shape of arectangle that compliments the rectangular shape of the applicatorcontact surface, but the length of one or both sides of the rectangle isadjustable such that the size of the mask can be increased and theirradiation surface of the applicator contact surface may be reduced. Inanother embodiment, the mask portion is similar to a photography shutterthan can be mechanically altered to increase the area covered by themask portion to expose less and less of the applicator contact surfacesuch that the irradiation surface is reduced.

Any number of suitable materials may be used to make the mask portion,such as, for example: aluminum, gold plated aluminum, ceramic, silverplated aluminum. In various aspects, it may be desirable to avoid themask portion from heating up during the treatment of the treatmentregion. In such aspects, the mask portion can be actively cooled toprevent heat build-up in the mask portion from impacting the subject.Exemplary means for active cooling include, for example, using athermoelectric cooler, air convection (fan), phase change material(ice), and a separate coolant circuit. Alternatively, the mask portioncan be passively cooled, for example, by fins that help move heat awayfrom the region of the mask portion. In such aspects, the fins wouldhave sufficient area and thermal contact to dissipate heat to thesurrounding ambient air or the frame of the fixture through conductionor convection. Ideally, the mask and any additional heat it accumulatesfrom the energy source (e.g., EMR, laser, RF) can be wicked away bybeing in intimate thermal contact with the existing window (e.g., asapphire surface) of the applicator, which is being actively cooled.

The one or more applicators can be held adjacent to the subject's face,neck, chin, or head by any of a number of approaches including by:strap/belt, gravity, positioning the patient's body area in a relativelycomfortable position relative to the applicator (e.g., applicator placedon a table top and chin placed on top of the applicator). Suitablestrap/belt systems used in orthodontia (e.g., head gear) and orthopedics(e.g., neck brace(s)) and modified in accordance with the presentteachings may be employed to maintain the applicator's contact surfacein desired contact with the area to be treated, for example, fortreatment of the face, neck, or chin.

With reference now to FIG. 15A, an exemplary sub-assembly is shown withan applicator 300, a frame 400, and a mask portion 450 coupled to theframe 400 and occluding a portion of the frame's aperture 404. Theunmasked portion 454 is in the shape a rectangle having a size reducedfrom the rectangle of the applicator's contact surface 307. Also shownis a contact sensor layer 461 that provides the same masking effect(modifies irradiation in the same size and shape) as the mask portion450, with the contact sensor layer 461 of the mask enabling the contactsensors 305 of the applicator 300 to be effective in the presence of themask 450. In this way, the contact detection capability as describedabove nonetheless remains available when the frame 400 is used inconjunction with the mask portion 450. The contact sensor layer 461 ofthe mask portion moves or offsets the effective contact sensors 460 tosurround the now unmasked portion 454 so that active contact sensingand/or passive contact sensing can be utilized to ensure contact of thesurface of the treatment region with the skin-contacting surface 307exposed by the unmasked portion 454. Any of the uses of a masked portiondisclosed herein may likewise employ a contact sensor layer 461 thatprovides an offset contact sensing capability, via offset contactsensors 460, that enables the contact sensors 305 present in theapplicator to nonetheless be effective in the presence of the maskportion 450. The contact sensor layer 461 may optionally include one ormore resistors 465 (shown in phantom) disposed between two adjacenteffective contact sensors 460. FIG. 15A shows the presence of fourresistors 465, though it is not necessary to have a resistor presentbetween each pair of contact sensors. The one or more resistors 465 maybe positioned on the side of the effective contact sensors 460 (the skincontacting side) or on the side of the contact sensor layer 461 that isadjacent the applicator surface. The resistor can be employed to providea signal to the system such that the system will be treating a reducedarea due to the presence of a mask 450. As a result of the resistor 465signal, the treatment parameters may be adjusted in accordance with thereduction in irradiation surface area provided by the unmasked portion454. Suitable system adjustments that can be made in response to thedetection of the presence of a masked portion are, for example,increased cooling to cool the masked portion or reduction of cooling dueto lesser surface area being treated. Other parameters that can beadjusted include, for example, the flux and/or the wavelength so as totreat the specific treatment area (e.g., submental area).

FIG. 15B shows a sub-assembly similar to FIG. 15A but differs in thatthe mask 450 defines an unmasked portion 454 having the shape of atrapezoid, where the unmasked portion 454 exposes from about 50% toabout 80% of the irradiation surface of the applicator skin-contactingsurface 307 As shown, the mask 450 includes four pairs (or eight total)of offset contact sensors 460 that effectively extend the applicatorcontact sensors present on the applicator surface similar to as is shownabove in FIG. 15A and labeled 305.

With reference now to FIGS. 32A-B and FIGS. 33A-B, another exemplarymask 450 in accordance with various aspects of the present teachings isdepicted, with FIG. 32A representing the side of the mask 450 facing theapplicator and FIG. 32B representing the side of the mask 450 configuredto be in contact with the patient's skin. FIG. 33A depicts the mask 450coupled to the frame 400 as seen from the applicator side, while FIG.33B depicts the patient-facing side of the exemplaryapplicator/frame/mask sub-assembly. As shown in FIGS. 32A-B, the mask450 generally comprises a substantially planar, conductive material 452(e.g., gold, metal, gold coated metal) through which the treatmentenergy does not pass (or its transmission is attenuated) and whichdefines an unmasked portion 454 that is generally in the shape of aparabola that is smaller than the window of the applicator to which themask 450 can be coupled. Though the generally parabolic shape of theunmasked portion 454 may be preferable for some treatments (e.g.,treatment of the submental region), a person skilled in the art willappreciate masks 450 in accordance with the present teachings can definea variety of shapes and sizes of one or more unmasked portions 454 forcontrolling the application of energy to the treatment region. Thoughthe mask 450 is shown and described above as generally having a planarpatient-contacting surface, the mask can include other profiles (e.g.,concavities). Nonetheless, in various aspects, a planar contact surfacecan be preferable to reduce/lessen air gaps between the mask and thetreatment area, which can provide improved control of the application ofthe treatment energy. In various aspects, it will be further appreciatedthat an appropriate mask 450 can be selected to match the particularanatomy of a patient (e.g., size and shape of the unmasked portion), forexample, and that the practitioner can selectively couple the mask tothe frame as otherwise discussed herein. By way of non-limiting example,the mask 450 can be configured to be releasably retained within theframe 400 via snap-fit, compression fit, or tension fit such that theframe and mask 450 can be placed against the treatment region and themask adjusted and/or replaced as necessary to provide for un-masking ofthe desired treatment region and/or masking of tissue that is not to betreated.

As noted above FIG. 32A represents the side of the mask 450 facing theapplicator and FIG. 32B represents the side of the mask 450 configuredto be in contact with the patient's skin. In accordance with variousaspects of the present teachings, the mask 450 can include an indicationof the proper orientation of the mask relative to the patient. By way ofexample, the mask 450 can be sided (e.g., via a fold) such that when themask 450 is in placed in the frame and on the subject, the practitionerwould know that the upper and lower face are properly oriented and/orthe aperture is facing the proper direction. Though the mask 450comprises a conductive material 452 (e.g., gold), in various aspects atleast a portion of the patient-facing surface shown in FIG. 32B can beinsulated, for example, with a polyamide coating 453 though it will beappreciated that a variety of insulating materials can be utilized. Asshown in FIG. 32B, the contact sensors 460 can be embedded within theinsulating coating and can communicate with contact sensing mechanism ofthe applicator as otherwise discussed herein In addition, in someaspects as shown in FIG. 32B, a border 455 of the conductive mask 450about the unmasked portion 454 may be left uncoated. It has been foundthat such an uncoated border having a width, e.g., between about 1 mmand about 10 mm wide, preferably from about 3 to about 6 mm wide, orfrom about 4 mm to about 5 mm wide) can provide for conductive cooling,while mitigating scattered edge effects of heating the treatment areathrough the aperture in the mask. For example, it was discovered thatwhen the mask was entirely insulated on the patient facing side of themask (e.g., there was no conductive border), scattered edge effects ofthe treatment energy was believed to pool in the tissue adjacent tothese edges causing undesirable overheating. Though any number ofsuitable materials may be used to make the mask portion, such asaluminum, gold plated aluminum, ceramic, silver plated aluminum, all byway of non-limiting example, a gold conductive cooling border 455 may bepreferred due to its biocompatibility, its conductivity, it ability toblock the treatment energy, and its effectiveness in reducing theundesirable heating edge effects.

FIG. 16A shows a sub-assembly of frame 400, including a mask 450, havingan unmasked portion 454 exposing a trapezoidal shape, with a pluralityof offset contact sensors 460 together with a belt system 500, which issimilar to a headgear used in orthodontia. FIG. 16B shows an assembly ofthe applicator 300 coupled with a frame (e.g., snap fit), including amask 450 that masks all but a trapezoidal portion of the applicatorcontact surface 307, the unmasked portion 454 having a trapezoidal shapethrough which a portion of the applicator contact surface 307 isexposed. The assembly also includes one or more offset contact sensors460, specifically, four offset contact sensors 460, all of which can besecured to the patient with a belt system. In various aspects, theunmasked portion 454 can expose from about 25% to about 80%, or about50% of the irradiation surface of the applicator's skin-contactingsurface 307. It will be appreciated that the amount of masking selectedto cover the contact surface can depend, for example, on the shapeand/or size of the subject's submental treatment area. FIGS. 16C-Ddepict the belt system 500 being used to place the masked frame 400under the chin so as to isolate the submental tissue for treatment 610.As shown in FIG. 16C, the belt system 500 is tightened at thesubmental/chin region 610 from either end of the frame 400, the beltsystem 500 traveling up both sides of the jaw line, in front of both ofthe ears and branching off into a Y shape with one portion strappingaround the front of the head 510 in the region of the forehead and theother portion strapping around the region of the back of the head and/orthe neck. As best shown in FIG. 16D, the submental region 610 is exposedby the trapezoidal shape of the unmasked portion 454 and thereby treatedby the applicator 300 when the skin-contacting surface 307 is in contactwith the surface of the submental tissue extending into the trapezoidalshaped unmasked portion 454. In addition to utilizing the belt 500 tosecure the frame/mask sub-assembly to the patient as shown in FIG. 16D,the subject of FIG. 16C is depicted as holding the applicator 300 incontact with the submental region 610. It will also be appreciated thatin some embodiments, not shown, the subject can be lying down andgravity and/or propped pillows can help to maintain contact between theunmasked skin-contacting surfaces of the applicator and the skinsurface. In still other embodiments, the subject can rest his chinagainst the applicator, which sits at a comfortable height on a tabletop (or in a construct similar to a slit lamp at an ophthalmologistoffice), the belt, optionally styled like a headgear used inorthodontia, helping to maintain proper placement of theapplicator/frame assembly, with the pressure from the chin rests alsohelping to ensure good contact. As discussed otherwise herein, theapplicator can be connected to the system via an umbilical (not shown).

FIG. 17A shows a sub-assembly of two frames 400, each including a mask450 defining an unmasked portion 454 having a rectangular shape,together with a belt system 500 having a chin strap 520 that attaches tothe two frames 400. FIG. 17B depicts the sub-assembly of FIG. 17A withtwo applicators 300 connected to the frames 400, each frame 400including an unmasked portion having a rectangular shape 454 surroundedby a masked portion and a belt system that attaches the two frames toone another and can be further joined together by two free ends toencircle and tighten around a subject's body portion. The unmaskedrectangular shape 454 exposes a portion of the contact surface 307 ofthe applicator 300. FIG. 17C shows the sub-assembly shown in FIG. 17Bwith the two masked applicators each providing an unmasked rectangularportion disposed in contact with the two jowl areas of the face (lefthand side and right hand side) above the jawline, with a chin strap 520portion of the belt 500 between the two frames 400 being securedadjacent the chin, and the two free ends 510 encircling the head andconnecting to one another just at the hairline above the forehead. Theunmasked portion of each of the frames enables from about 20% to about50% of the contact surface area of each of the applicators to be incontact with and treat a respective jowl portion. Here, in addition tothe belt, the subject is holding the applicators in contact with thejowl area. In another embodiment, not shown, the subject can be lyingdown, with gravity and/or propped pillows helping to maintain contactbetween the unmasked contact surfaces of the applicators and the skinsurface. As discussed otherwise herein, the applicator can be connectedto the system via an umbilical (not shown).

With reference now to FIGS. 18A-E, the sub-assembly includes two frames400C (shown also in FIG. 8 ), with each frame 400C being coupled to amask 450, where the unmasked portions 454 have a rectangular shape. Thetwo frames 400C are connected to one another by a hinge 441. FIG. 18Bshows the two masked hinged frames of FIG. 18A being held against thesubmental region 610, where the unmasked portions 454 reveal a left handside and the right hand side of the submental region 610 with each sidebeing isolated for tissue treatment by the unmasked portion 454 of theframe 400. The unmasked portion 454 enables irradiation from about 40%to about 75% of each of the applicator contact surfaces 307 to bedelivered to the respective treatment areas (see FIG. 18C). FIG. 18Cshows the two masked hinged frames of FIG. 18A together with anapplicator 300A. FIG. 18D shows the two masked hinged frames of FIG. 18Asnap fit attached to two applicators, revealing a substantiallyrectangular portion of the applicators' contact surfaces 307 through theunmasked portion 454 unobstructed by the mask 450. As discussed above, abelt 500 can also be attached to the frames 400C and can be used tosecure the applicators 300 together with the frames about a portion of asubject's body (e.g., to surround the subject's head) FIG. 18E shows anassembly of two applicators 300A, 300B snap fit to the two masked hingedframes 400C of FIGS. 18A-D in contact with the submental region 610 of asubject. Here, the subject is holding the assemblies in contact with thesubmental region 610, though additionally or alternatively, the belt 500shown in FIG. 18D may be used to secure the applicators to the submentalregion by encircling the belt around the head. In still anotherembodiment as otherwise discussed herein, the subject can rest his chinagainst the applicators, which can sit at a comfortable height on atable top, for example. As discussed above, the applicator can beconnected to the system via an umbilical (not shown).

With reference now to FIGS. 19A-C, a hinged frame 400D defining threeapertures 404 is coupled to a mask 450 defining three unmasked portions454 having a rectangular shape Tabs 408B include multiple belt loops 407on either side of the frame 400D and enable the frame to be angled byusing, for example, an upper belt loop on the left side and a lower beltloop on the right side. Though two belt loops 407 are shown on eitherside, it will be appreciated that a frame could employ any of a numberof belt loops 407 so that the desired angling or positioning of theframe on the body can be achieved. For example, where six loops arepresent on a frame on the left side, the top loop can be used and on theright side the bottom loop can be used, this way desired positioning canbe achieved for any of a number of body areas, not limited to the neckarea, as shown here. In one embodiment, there is one belt loop on twosides of a frame. In another embodiment, more than one belt loop can bepresent on two sides of the frame.

FIG. 198 shows the three masked hinged frames 400D of FIG. 19A heldagainst the neck region, where the unmasked portion 454 reveal threeportions of the neck region 600 that are isolated for tissue treatment.FIG. 19C shows the three masked, hinged frames of FIG. 19A snap fitattached to two applicators 300A, 300B revealing a substantiallyrectangular shaped contact surface 307 of each applicator through theunmasked portion 454 of two of the apertures of the frame 400D, with thecenter masked frame 400D not being attached to an applicator. As shown,a belt 500 is attached to the frame 400D to secure the applicators abouta portion of a subject's body (e.g., about a subject's head). FIG. 19Dshows an assembly of two applicators 300A and 3008 snap fit to the frame400D and associated with two of the three apertures as shown in FIGS.19A-C, the attached applicators being in contact with the neck region,with the subject holding the two applicators 300A, 300B in contact withthe neck region. In another embodiment, not shown, the belt 510 can beused to secure the applicators 300A, 3008 and their masked frames 400Dagainst the neck region by encircling the back of the neck. As discussedotherwise herein, the applicator can be connected to the system via anumbilical (not shown).

With reference now to FIGS. 20A-C, a masked frame 400F is depicted inwhich the unmasked portion 454 of the apertures of the frames 400F havea rectangular shape. The frames 400F are hinged 441A on their shortside. FIG. 20B shows the masked, hinged frame 400F of FIG. 20A snap fitattached to the two applicators 300A, 300B, revealing a substantiallyrectangular portion of applicators' skin-contacting surface 307 throughthe unmasked portion 454. As shown, a belt 500 is also attached to theframe 400F and can be used to secure the applicators about a portion ofa subject's body, e.g., about the face or neck. FIG. 20C shows theassembly of two applicators 300A, 300B, snap fit to rectangular theframe 400D that is hinged 441A on the short side, the unmasked portion454 of the contact surface (shown in FIG. 20B) in contact with the neckregion of a subject, with the subject holding the assemblies in contactwith the neck region under the jawline. In another embodiment, notshown, the belt 500 can be used to secure the applicators against theneck region by encircling the back of the neck. In still anotherembodiment, the subject can be lying down on his back and the force ofgravity, optionally together with propped pillows, can also helpmaintain contact between the unmasked portions of the applicator contactsurface and the treatment area. As discussed otherwise herein, theapplicator can be connected to the system via an umbilical (not shown).

FIGS. 21A-C shows two masked frames 400F, where the unmasked portion 454of the frame apertures 404 have a rectangular shape. The frames 400F arehinged 441B on their short side. The hinges 441B depicted in FIGS. 21A-Coffer a greater range of motion and adjustability relative to the hinges441A shown in FIGS. 20A-C, which can enable treatment of different areasand/or subjects having more fullness in the neck region. FIG. 21B showsthe two masked, hinged frame 400F of FIG. 21A snap fit attached to thetwo applicators 300A, 300B revealing a substantially rectangular shapedsurface of each applicator's skin contact surface 307 through theunmasked portion 454 of the mask 450. The unmasked portion 454 revealsfrom about 60% to about 80% of the available contact surface 307 of theapplicator 300A, 300B. A belt 500 is attached to the frames 400F and canbe used to secure the applicators together with the masked frames abouta portion of a subject's body. FIG. 21C shows an assembly of twoapplicators 300A,B snap fit to the frame 400F of FIGS. 21A and 21B, withthe skin-contacting surface 307 of the applicator being in contact withthe isolated a portion of the isolated treatment region extendingthrough the apertures 404 of the frame, with the subject holding theassemblies in contact with the neck region under the jawline. In anotherembodiment, not shown, the belt 500 can be used to secure theapplicators against the neck region by encircling the back of the neck.In still another embodiment, the subject can be lying down on his backand the force of gravity, optionally together with propped pillows, canalso help maintain contact between the unmasked portions of theapplicator contact surface and the treatment area. As discussedotherwise herein, the applicator can be connected to the system via anumbilical (not shown).

With reference now to FIGS. 22A-C, an applicator 300, a frame 400including a mask 450 defining an unmasked portion 454, and a non-planar,contoured skin-contacting portion 700 is depicted. FIG. 22B shows theassembly of the applicator 300 attached to the frame 400, the mask 450(defining the unmasked portion 454) and the contoured portion 700. FIG.22C shows the sub-assembly of the applicator 300 removably attached tothe masked frame 400, with the contoured portion 700 being held adjacentthe submental treatment by the subject's hand. It will be appreciatedthat just as the contoured portion 700 can be shaped so as to form fitthe submental convex region, other shapes are possible to match thecontour of the treatment region. In some aspects, the contoured portioncan limit the amount of contact enabled between the submental region andthe applicator contact surface. In this way, a mask can, in someembodiments, be avoided. Rather, the access provided by the contouredportion can limit the effective irradiation surface of the contactsurface 307 of the applicator 300.

In another embodiment, not shown, the subject can be lying down withgravity and/or propped pillows helping to maintain contact between theunmasked contact surfaces of the applicator and the skin surface. Instill another embodiment, the subject can rest his chin against theapplicator, which can sit at a comfortable height on a table top, forexample, with the pressure from the chin resting against the applicatorhelping to ensure good contact for treatment. Optionally, a belt (notshown) from either side of the frame can encircle the subject's head tohelp maintain proper placement of the applicator/frame assembly, withthe pressure from the chin rest also helping ensure good contact. Insome embodiments, a contact sensor that may be offset from theapplicator contact sensor can be coupled to the frame and/or thecontoured portion 700 of the frame. As discussed otherwise herein, theapplicator can be connected to the system via an umbilical (not shown).

With reference now to FIG. 23 , an exemplary table top stand 550 isdepicted having an adjustable mask 450 positioned thereon. The table-topstand 550 (e.g., similar to a slitlamp used in ophthalmology) can bepositioned at a height comfortable to the subject. As shown, anapplicator 300 can be positioned under a frame 400 on top of which sitsthe masked portion 450. As otherwise discussed herein, the applicator300 can connect to the table top 550 stand via a coupling with frame 400(e.g., a snap fit). As shown in inset, the size of the mask 450 can beadjustable to provide a relatively larger unmasked portion 454A or arelatively smaller unmasked portion 454B, thereby exposing more or lessof the applicator contact surface 307 as desired. The adjustment of themasked portion relative to the unmasked portion can be adjusteddepending, for example, on the size of the submental region of thesubject to be treated.

As shown in FIG. 23 , the subject can rest his submental area 610 on theadjusted mask portion 450 for treatment of the portion that remainsunmasked 454. Optionally, chin rests 750 can be placed between the mask450 and the subject's chin to ensure good positioning of the submentalarea on the skin-contacting surface 307. Optionally, the adjustable maskand/or the chin rests can include contact sensors (e.g., such as offsetcontact sensors 460 described above) that extend the effectiveness ofthe contact sensors 305 to ensure contact of the treatment region ofwith the contact surface 307 exposed by the unmasked portion 454. Insome embodiments, the mask and/or the chin rests can provide a heat sinkto ensure that the masked area is comfortable to the subject.

The systems of treatment of the face, neck, chin, and jaw disclosedherein may use the exemplary system 100 disclosed in association withFIG. 1 . In some embodiments, one or more umbilical cords 405 may betemporarily freed or removed from the arm 420 and the brake mechanism410 to enable a greater range of motion of the applicator(s) 300 and theumbilical cord(s) 400 for treatment in accordance with any of theapplications disclosed in association with FIGS. 14-23 .

As noted above, in accordance with various aspects of the presentteachings, a harness can be provided to facilitate treatment ofparticular portions of a patient's body including of the head or neckregion, for example, by improving patient comfort as the treatment isbeing applied, to ensure effective contact with the treatment region foreffective coupling of the treatment energy into the skin, and/or toimprove patient safety. With reference now to FIGS. 24-31, anotherexemplary harness for use in the treatment of a subject's head or neckregion (e.g., the submental region, the cheeks, the portion of the cheekat or below the cheek bones, and the jowls) will now be described. Asshown in FIG. 24A-C, an exemplary harness 2400 in accordance withvarious aspects of the present teachings can be removably secured on apatient's head. As discussed otherwise herein, the harness 2400 can beconfigured to be coupled to a treatment applicator (e.g., applicator2408 depicted in FIG. 24C) so as to maintain the treatment applicator2408 in a fixed position relative to the treatment region during thecourse of the treatment. As shown in FIGS. 24A-C and as will bediscussed in more detail below, the exemplary harness 2400 generallycomprises headgear 2410 that is configured to be secured to thepatient's head that can be coupled to a frame 2404 via one or moreconnectors 2420 such that the frame 2404 can be maintained against thesubmental region. As will be appreciated by a person skilled in the artin light of the present teachings, the exemplary harness 2400 enablestreatments to be performed by having the practitioner set-up theheadgear 2410, frame 2404, and applicator 2408, and start the treatment,thereafter allowing the treatment to proceed without the continuedpresence of the practitioner and having the patient standing, sitting,or lying. With reference now to FIG. 24D-E, it can be seen that theexemplary harness 2400 can be reconfigured to treat additional regionsof the subject's head. As shown in FIG. 24D-E, the exemplary harness2400 is removably secured on a patient's head and can maintain thetreatment applicator 2408 in a fixed position relative to the patient'sjowl treatment region during the course of the treatment. As discussedotherwise herein, the coupling of the connectors 2420 with the headgear2410 and/or their length can be adjusted to accommodate particulartreatment regions.

Additional details of the exemplary harness 2400 in accordance withvarious aspects of the present teachings will now be discussed in moredetails with reference to FIGS. 25-31 . As shown in these figures, theheadgear 2410 of the harness 2400 generally comprises an encirclingportion 2804 that is configured to encircle (e.g., go around) thepatient's head, for example, above the level of the patient's ears. Theencircling portion 2804 may contact all or a portion of the subject'shead's circumference. As shown in FIGS. 28A-B, the anterior section 2804a of the encircling portion can be disposed against the patient'sforehead, and can, for example, comprise a padded material so as toincrease the patient's comfort when the harness is secured to thepatient's head. The padded material 2805 used in the anterior section2804 a is shown in detail in FIG. 29 . The encircling portion 2804 canalso comprise a rear section 2804 p (made of the same or differentmaterial as the anterior section 2804 a) that is configured to besecured against the posterior side of the patient's head, for example,in the region of the occipital lobe. In various aspects, the rearsection 2804 p can be rotated (e.g., via rotatable hub 2807) and/or alength (e.g., a circumference) of the encircling portion 2804 can beadjusted via an adjustment mechanism to help ensure that the harness2400 is securely coupled to the patient's head. As best shown in FIGS.26 and 30 , for example, the rear section 2804 p of the encirclingportion 2804 can comprise two rearwardly extending straps 2806 a and2806 b that are coupled to one another in the region of the patient'soccipital lobe, the coupling of which can be adjusted (e.g., by snapfit, sliding, compression fit, etc.) so as to alter the length of therear section 2804 p. As shown in FIG. 31B, for example, a knob of anadjustment mechanism 2812 can thus be rotated to increase or decreasethe overlap of the straps 2806 a,b so as to adjust the size of the rearsection 2804 p to conform to the back of the patient's head. As shown,the straps 2806 a,b can be coupled to the anterior section 2804 a at arotatable hub such that the angle of the rear section 2804 p can bechanged relative to the anterior section 2804 a.

Additionally, referring now to FIG. 28A, in some aspects, the headgear2410 can include a superior connector 2608 extending between lateralsides of the encircling portion 2804 (e.g., in the subject's templeregion) that can be disposed against the top of the patient's head toprovide additional support to the harness 2400. In various aspects, thesuperior connector 2608 can be rotated and/or a length of the superiorconnector 2608 can be adjusted via an adjustment mechanism 2612 to helpensure that the harness 2400 is secured to the patient's head. As shownin FIG. 26 , for example, the superior connector 2608 can comprise twoupwardly extending straps 2610 a and 2610 b that overlap each otherwithin an adjustment mechanism 2612. In such aspects, a knob of theadjustment mechanism 2612 can thus be rotated to increase or decreasethe overlap of the straps 2610 a,b so as to adjust the size of thesuperior connector 2608 to lie against the top of the patient's head. Asshown, the straps 2610 a,b can also be rotatably coupled to the headgear2410 at a rotatable hub such that the angle of the superior connector2608 can be changed relative to the anterior section 2804 a.

With particular reference now to FIGS. 27 and 28A-B, the headgear 2410additionally includes a brim 2700 that extends anteriorly from lateralsides of the encircling portion 2804 (e.g., in the region of thepatient's temple) and generally across the subject's forehead. As shownin the figures, the exemplary brim 2700 comprises a frontal longitudinalbar 2726 that is generally disposed horizontally across the patient'sforehead and that extends between a first lateral end 2726 a and asecond lateral end 2726 b on opposed sides of the centerline of thesubject's face. From each of the opposed lateral ends 2726 a,b, laterallongitudinal bars 2728 a,b extend posteriorly and terminate in aposterior end that is configured to be coupled to the encircling portion2804, for example, in a generally rigid connection so as to supportand/or compress the frame 2404 against the patient's treatment area(e.g., the submental region) upon coupling via connectors 2420 a,b (asshown in FIGS. 24A,B). It will be appreciated that the frontallongitudinal bar 2726 and the lateral longitudinal bars 2728 a,b can bea single unitary piece (e.g., generally rigid plastic) or can comprisemultiple pieces coupled to one another (e.g., directly or indirectly) soas to form the brim 2700. The one or more segments of the brim 2700 canbe straight, curved, or a combination of both, and can be made of avariety of materials such as a metal, plastic, resin, polymer,composite, or any combination thereof, all by way of non-limitingexample.

With continued reference to FIGS. 24A-C and 27, the brim 2700additionally comprises a plurality of anterior coupling elements 2722(i.e., two or more) on each lateral side of the centerline (C), each ofwhich is configured to removably couple the brim 2700 to the frame 2404via one or more anterior connectors 2420 a having a corresponding matingelement that can couple to each of the anterior coupling elements 2722.As shown, three anterior coupling elements 2722 are disposed on each ofthe lateral longitudinal bars 2728 a,b, though it will be appreciatedthat more and fewer anterior coupling elements 2722 can be provided andthat they can be disposed at a variety of locations along the brim 2700such that in some embodiments the anterior coupling elements 2722 oneach lateral side are spaced anteriorly relative to one another. In thismanner, the one or more anterior connectors 2420 a,b can be removablycoupled, de-coupled, and re-positioned (e.g., coupled to a differentanterior coupling element 2722) such that the angle of the anteriorconnectors 2420 a,b between the frame 4204 and the brim 2700 can beselected to optimize the positioning of the frame 4204 on the treatmentregion (e.g., the submental region) according to the patient's anatomyand/or to aid patient comfort. In addition to the exemplary descriptionabove with respect to the treatment of the patient's submental region,referring now to FIGS. 24D-E, the plurality of anterior couplingelements 2722 can in some aspects allow for the treatment of a varietyof treatment regions of the subject's head (e.g., jowls, cheeks) byenabling the proper positioning and orientation of one or more frames2404 relative to the desired treatment region and/or by adjusting theangle and/or length of the connectors 2420 coupling with the brim 2700.As shown in FIGS. 24D-24E, the frame can be offset relative to thecenterline to treat one lower cheek/jowl area on one lateral side of thesubject, here, the selection of desired anterior coupling elements 2722and the length and/or angle of the connectors 2420 is adjusted to enablethe lower check/jowl area to be in contact with the frame 2404. Inaddition, the practitioner may select a mask having an aperture suitedto the treatment area. A secondary treatment may optionally be performedto address the lower cheek/jowl area of the subject to assure asymmetrical treatment result. By way of example, in some aspects aplurality of frames can be provided (e.g., for simultaneous treatment ofboth jowls or both cheeks on both sides of the subject's head), and theframes can be connected (e.g., via strap passing under the patient'schin) with mating elements from one lateral side of each frame beingcoupled to the anterior coupling elements on that lateral side of thebrim via an anterior connector. Here two applicators will be utilizedeach with one of the two frames, one on each jowl or cheek.

As will be appreciated by a person skilled in the art in view of thepresent teachings, referring to FIGS. 24A-C, the anterior couplingelements 2722 and the anterior connector(s) 2420 a,b can be configuredto removably couple to one another (e.g., so as to allow for adjustmentas otherwise described herein) in a variety of manners. As shown, forexample, in FIGS. 27 and 28A-B, the exemplary anterior coupling elements2722 can comprise a plurality of identical key holes having a widesuperior portion 2724 and a narrower inferior portion 2726 such that acorresponding male mating element on the superior end of the anteriorconnector(s) 2420 a,b can be inserted into the wide superior portion2724 and can be retained (as with a button) within the narrower inferiorportion 2726 of the coupling element 2722 (e.g., by tightening theconnector or by tension generated by a flexible connector). It will beappreciated that the corresponding coupling elements 2722 of the brim2700 and the mating elements of the connectors 2420 a,b can be coupledvia one or more of snap-fit, compression fit, tension fit, male-femaleattachment, clamp, clip, hook and eye, clothespin, buckle, bungee, orzip tie etc., all by way of non-limiting example.

As discussed above, and referring to FIGS. 24A-C, the harness 2400 canadditionally include one or more anterior connectors 2420 a,b that areconfigured to extend between the brim 2700 and the frame 2404 forcomfortably retaining the frame at a desired location within thetreatment region (e.g., the submental region). The anterior connectors2420 a,b can have a variety of configurations through are shown in theexemplary depicted harness 2400 as being a strap that can extend from asuperior end 2412 having a mating element 2412 a configured to couple toone of the corresponding anterior coupling elements 2722 to an inferiorend 2414 having a mating element 2414 a configured to couple to acorresponding coupling element formed on the frame 2404 (as discussedotherwise herein). As discussed above, the superior and inferior matingelements 2412 a and 2414 a of the connectors 2420 a,b can have a varietyof configurations for removably coupling to the corresponding anteriorcoupling elements 2722 formed on the brim 2700 and/or frame 2404 (e.g.,one or more of snap-fit, compression fit, tension fit, male-femaleattachment, clamp, clip, hook and eye, clothespin, buckle, bungee, orzip tie etc.).

Alternatively, in some aspects, it will be appreciated that a singleanterior connector 2420 having an anterior coupling element (e.g., 2412a) on each end thereof can, for example, extend through a loop on theframe 2404, with each of the mating elements 2414 a being removablycoupled to anterior coupling elements 2722 on opposed lateral sides ofthe brim 2700 Additionally, in some aspects, a length of the one or moreanterior connector(s) 2420 can be adjustable (e.g., via an adjustablebuckle) so as to increase or decrease a tension on the connector(s) tohelp maintain contact and/or patient comfort. In some aspects, forexample, the length of the anterior connector(s) 2420 can be adjustedafter its mating elements are coupled to the brim 2700 and/or frame2404.

With particular reference now to FIGS. 28A-8 , the encircling portion2804 can additionally comprise at least one posterior coupling elements2808 a,b on each lateral side of the centerline, each of which isconfigured to removably couple the harness 2400 at arelatively-posterior location to the frame 2404 via one or moreposterior connectors 2420 c,d (only one of the posterior couplingelements 2808 is shown). Though only one posterior coupling element 2808a,b is shown as being disposed on each lateral side of the subject'shead (e.g., behind the ear), it will be appreciated that more and fewerposterior coupling elements 2808 a,b can be provided and that they canbe disposed at a variety of posteriorly-spaced locations along theencircling portion 2804 (e.g., directly above the patient's ear, behindthe patient's ear) to allow for adjustment of the angle of the posteriorconnectors 2420 c,d. It will also be appreciated that the posteriorcoupling elements 2808 a,b can couple the frame 2404 to the harness 2400at a different angle from the anterior connectors 2420 a,b to optimizecontact with the treatment region (e.g., the submental region) and/or toaid patient comfort, for example, depending on the patient's anatomy.Like the anterior connectors 2420 a,b, a length of the posteriorconnectors 2420 a,b can also be adjusted (i.e., increased or decreased)to help maintain contact and/or comfort. In one exemplary embodiment,the posterior coupling elements 2808 and the anterior coupling elements2722 are the same and as such the posterior connectors 2420 c,d can beinterchangeable with anterior connectors 2420 a,b.

Positioning of the anterior coupling elements 2722 on the brim 2700anterior to the subject's forehead enables the connectors 2420 a, b tosupport the frame in such a way that good contact of the frame, mask,and/or applicator is present between the head and neck treatment regionwhile maintaining a comfortable position of the frame, mask, and/orapplicator relative to the subject's neck. The position of the posteriorcoupling elements and their connectors 2420 c,d likewise enables acomfortable position to be maintained. Further, positioning theplurality of coupling elements 2722 on the brim 2700 anterior to thesubject's forehead increases the number of head shapes and types thatcan be treated using the system described herein. Further still, thisconfiguration enables a subject to comfortably wear glasses (includingsafety glasses that are necessary for at least some treatment energymodalities) without the risk that the glasses will be pushed off by theharness during the treatment. The subject enjoys the ability to move hishead during the treatment and comfortably sit, stand, or lie down. Thesubject can read, work on the computer and/or comfortably hold aconversation while wearing the harness during his treatment. The subjectis not enclosed by the harness, so he is unlikely to feel claustrophobicor trapped and his harness can be adjusted to ensure that his neck isnot contacted by a portion of the side of the frame and/or applicator,in this way a feeling of choking and/or windpipe contact is avoided.

The systems and methods disclosed herein is discussed in relation totreatment of body areas having undesired fat and bulges. The disclosedsystem and method of treatment of external treatment of the body of asubject may applied to other treatment modalities that are external tothe body (e.g., non-invasive) such as, for example, pain treatment, acnetreatment, wound treatment, skin rejuvenation, and/or skin tightening.

In one aspect, this disclosure relates to a system for substantiallyunattended treatment including a frame encircling at least portion of acircumference of a body region. The frame has at least one aperturesized to isolate at least one portion of a body region and the frame hasa first fastening member. The system also includes an applicator havinga skin contacting surface. The applicator has a second fastening memberthat detachably fastens with the first fastening member when theapplicator is inserted into the frame. In one embodiment, the firstfastening member and the second fastening member include a male memberand a female member that snap fit. In one embodiment, at least twoframes of a plurality of frames are attached to one another by a hinge.

The system can include a belt and the frame is removably attached to thebelt. All or a portion of the belt may be flexible. All or a portion ofthe belt can encircle the portion of the circumference of the bodyregion

In one embodiment, the applicator emits hyperthermic energy through theskin contacting surface.

In one aspect, this disclosure relates to a system for substantiallyunattended treatment including a frame encircling at least portion of acircumference of a body region. The frame has at least one aperturesized to isolate at least one portion of a body region and the frame hasa first fastening member. The system also includes an applicator havinga skin contacting surface. The applicator has a second fastening memberthat detachably fastens with the first fastening member when theapplicator is inserted into the frame. In one embodiment, the umbilicalcord has a first end coupled to an energy source and a second endcoupled to the applicator. In some embodiments, the system includes anarm having a braking mechanism. A portion of the umbilical cord betweenthe two ends is threaded through the breaking mechanism and the breakingmechanism holds a portion of the umbilical cord selected by the user sothat the position of umbilical cord that lies between the breakingmechanism and the applicator enables the desired contact between theapplicator skin contact surface and the portion of the body.

In another aspect, the disclosure relates to methods of treatment of abody region using a frame having, at least one aperture to isolate abody region and then bringing the contact surface of an applicator incontact with the body region by fastening the applicator to the frameand treating the body region for any of a number conditions such asunwanted fat bulges, acne, pain, wound healing, and loose skin via thisnon-invasive approach.

While the foregoing figures and examples refer to specific elements,this is intended to be by way of example and illustration only and notby way of limitation. It should be appreciated by the person skilled inthe art that various changes can be made in form and details to thedisclosed embodiments without departing from the scope of the teachingsencompassed by the appended claims.

The invention claimed is:
 1. A non-invasive method of photothermallytreating tissue of a patient's head or neck comprising: coupling aharness to the head of the patient, the harness comprising a brim and aplurality of coupling elements; coupling a first frame to a patient'shead or neck in a fixed position relative to a first region of tissue,wherein the first region is disposed on the head or the neck; framingthe first region of tissue such that a surface thereof extends into anaperture defined by the first frame, wherein the first frame is coupledto the harness; coupling a first applicator to the first frame, thefirst applicator comprising a window defining a skin-contacting surfaceoperable to transmit treatment energy to the surface; and transmittingtreatment energy to a portion of the surface.
 2. The method of claim 1further comprising generating treatment energy by at least one source ofelectromagnetic radiation disposed in a housing.
 3. The method of claim2 further comprising delivering treatment energy to the first applicatorvia an umbilical cord extending from the housing to a distal end that iscoupled to the first applicator.
 4. The method of claim 2, wherein thesource of electromagnetic radiation utilizes a wavelength within a rangeof about 800 nm to about 1300 nm.
 5. The method of claim 2 furthercomprising maintaining a mean tissue temperature at the first regionwithin a range of from about 40 degrees Celsius to about 48 degreesCelsius.
 6. The method of claim 1, wherein the first region is asubmental region.
 7. The method of claim 1 further comprising applying amask relative to the aperture defined by the first frame.
 8. The methodof claim 7 further comprising defining an unmasked first portion havingan area smaller than the aperture.
 9. The method of claim 8 wherein thesurface of the first region of tissue receives treatment energy throughthe unmasked first portion.
 10. The method of claim 7 further comprisingadjusting at least one of size and shape of an unmasked first portiondefined by the mask to customize to which tissue treatment energy isapplied.
 11. The method of claim 6 further comprising adjusting at leastone of flux and wavelength to configure treatment energy for submentaltissue treatment.
 12. The method of claim 6 further comprising coolingthe submental region.
 13. The method of claim 1 further comprisingtightening a belt system of the harness.
 14. The method of claim 13,wherein the belt system is positioned to travel relative to one or bothsides of patient's jawline.
 15. The method of claim 1 further comprisingadjusting an encircling portion of the harness to securely couple theharness to the patient's head.
 16. The method of claim 15, wherein theencircling portion of the harness is adjusted using a rotatable knob.17. The method of claim 1 further comprising removably coupling brim tothe first frame.
 18. The method of claim 1 further comprising adjustinga superior connector of the harness to securely couple harness to thepatient's head.
 19. The method of claim 18, wherein the superiorconnector is adjusted using a rotatable knob.
 20. The method of claim 1further comprising coupling a second frame to a patient's head or neckin a fixed position relative to a second region of tissue, wherein thesecond region is disposed on the head or the neck, wherein the secondframe is coupled to the harness; framing the second region of tissuesuch that a surface thereof extends into an aperture defined by thesecond frame; and coupling a second applicator to the second frame, thesecond applicator comprising a window defining a skin-contacting surfaceoperable to transmit treatment energy to the surface of the secondregion.